State of Louisiana v. FDA — 5th Cir. (argued September 9, 2026)
The Fifth Circuit hears State of Louisiana v. FDA. Louisiana seeks a stay of the FDA's 2023 mifepristone REMS, a drug-safety program that removed in-person dispensing and added pharmacy certification. The district court denied that relief and paused the case for FDA review. The appeal centers on Louisiana's Article III standing and whether the Fifth Circuit may issue a Section 705 stay after the Supreme Court stayed an earlier Fifth Circuit order.
State of Louisiana v. FDA (No. 26-30203) — U.S. Court of Appeals for the Fifth Circuit, argued September 9, 2026.
Sources
Argument audio — U.S. Court of Appeals for the Fifth Circuit (public domain, 17 U.S.C. § 105):https://www.ca5.uscourts.gov/OralArgRecordings/26/26-30203_09-09-2026.mp3
Argument listing — U.S. Court of Appeals for the Fifth Circuit:https://www.ca5.uscourts.gov/oral-argument-recordings/results?from=2026-08-01&to=2026-09-09
Fifth Circuit and district-court orders — appendix in Supreme Court docket 25A1208:https://www.supremecourt.gov/DocketPDF/25/25A1208/407856/20260502171524114_GBP%20FINAL%20Application%20-%20Appendix%2005-02%20rtf.pdf
Supreme Court stay docket — No. 25A1208:https://www.supremecourt.gov/docket/docketfiles/html/public/25A1208.html
Mifepristone REMS questions and answers — U.S. Food and Drug Administration:https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/questions-and-answers-mifepristone-medical-termination-pregnancy-through-ten-weeks-gestation
5 U.S.C. § 705 — U.S. House Office of the Law Revision Counsel:https://uscode.house.gov/view.xhtml?edition=prelim&num=0&req=granuleid%3AUSC-prelim-title5-section705
21 U.S.C. § 355-1 — U.S. House Office of the Law Revision Counsel:https://uscode.house.gov/view.xhtml?req=%28title%3A21%20section%3A355-1%20edition%3Aprelim%29
FDA v. Alliance for Hippocratic Medicine — Supreme Court opinion:https://www.supremecourt.gov/opinions/23pdf/23-235_n7ip.pdf
FDA Adverse Event Reporting System database — FDA:https://www.fda.gov/drugs/drug-approvals-and-databases/fda-adverse-event-reporting-system-faers-database
FAERS data limitations — FDA:https://fis.fda.gov/extensions/FPD-FAQ/FPD-FAQ.html
Postmarket drug-safety report — U.S. Government Accountability Office:https://www.gao.gov/assets/gao-10-68.pdf
FAERS interpretation guide — National Library of Medicine:https://pmc.ncbi.nlm.nih.gov/articles/PMC12393772/
- 0:00Introduction
- 2:08Section 705 stay
- 7:00Article III standing
- 50:21FAERS